BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1159152 · Received September 12, 2008

    Report

    Report Number
    1823260-2008-06852
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    July 4, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K930979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    NO DEATH REPORTED. CUSTOMER REPORTED AN INCIDENT OF HYPOGLYCEMIA THAT OCCURRED TWO MONTHS AGO REQUIRING PROFESSIONAL MEDICAL TREATMENT AT A TIME WHEN SHE WAS UNABLE TO USE HER ADVANTAGE SYSTEM DUE TO NO POWER. SHE HAD SYMPTOMS OF HYPOGLYCEMIA, ATTEMPTED TO TEST WITH THE ADVANTAGE, METER HAD NO POWER. SHE PASSED OUT, CO-WORKERS CALLED EMT'S WHO TREATED HER AND TRANSPORTED HER TO A HOSPITAL WHERE SHE WAS TREATED AND RELEASED. SHE ALSO REPORTED THAT TWO MONTHS PRIOR TO THIS INCIDENT, THE METER AND STRIPS WERE LEFT IN THE CAR IN THE SUN FOR A LONG TIME' AFTER WHICH THE SCREEN DISPLAY TURNED BLUE/GREEN. ATTEMPTED TO USE THE METER AT THAT TIME, DISPLAY SHOWED MISSING SEGMENTS, METER POWER THEN FAILED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE - CGA CGA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention METFORMIN 500 MG/DAY 8 YEARS